从“这不可能”中破局：药明康德以“三倍速度”赢得客户长期信任 | Bilingual

信任，是弥足珍贵的资产。而信任并非一蹴而就，它是在一次又一次高效、高质量的项目交付中，点滴积累、不断沉淀而成。在药明康德，这正是团队与客户彼此成就的日常。

数年前，药明康德子公司合全药业接到一个富有挑战性的项目：某家合作伙伴正计划从一家生物科技公司引进一款颇具前景的药物，并希望委托给合全药业负责生产。

该分子工艺复杂、单步耗时近20天，副反应多，收率波动明显。面对这些难题，合全药业团队基于一系列系统性分析和工艺优化，仅用2个月就攻克了技术难点，顺利完成了工艺转移与确认。

然而，当项目时间表摆在那家生物科技公司面前时，对方的反应却出乎意料：

“这不可能实现。”对方直言，“你们的速度是原先供应商的三倍。要么质量不过关，要么其中有什么‘猫腻’。”

面对质疑，项目团队没有多做辩解，而是选择用事实回应。

他们迅速生产了一批样品，交给对方检测。这款分子的合成一共需要十步反应，每完成一步，团队就将合成的中间体送往对方指定的独立实验室进行检测与放行。确认无误后，再进行下一步。

图片来源：123RF

对方的认可来得比预期更快。验证尚未全部完成，团队便收到了这家生物科技公司的回复：“不需要继续验证了，项目立即启动。”

从那一刻起，质疑转化为信任，项目也开始全面推进。

一体化平台能力，助力攻克数个关键挑战

一年多后，该项目进入验证生产阶段。在药明康德一体化CRDMO平台的高效协同之下，项目团队与客户紧密协作，制定了切实可行的项目计划，并提前做好风险预判。面对时间紧、需求多变等挑战，团队顺利攻克了多个技术难关，推动项目稳步前行。

在工艺研发方面，原工艺中某个中间体存在溶剂残留难以烘干的难题，团队凭借丰富的生产经验及工艺工程平台，通过一系列优化操作，使溶残一次性达到合格标准——后续生产无需再经过原本繁琐的烘料循环，效率显著提升。

在分析方面，团队充分尊重客户对原有分析方法的坚持，同时严格遵守不同地区的申报法规要求。依托公司一体化分析平台，团队高效完成了50余项方法验证与确认、约30项对照品与杂质的标化及结构确证，以及10余项稳定性及影响因素研究，为项目推进提供了有力保障。

最终，在研发、生产、分析等各团队的通力合作下，合全药业团队仅用7个月，就以“零偏差”的质量稳定性，完成了工艺性能确认（PPQ）批次的生产与交付。

当项目进入NDA申报的关键节点，新的考验随之而来。申报团队遇到了预期之中的发补问题。由于项目以另一地区的申报资料作为主体开展本地申报，而不同国家和地区的申报标准存在差异，推进过程中出现了十多项需补充和修改的材料，涉及生产工艺、分析方法等方面。按照常规流程，这类工作需耗时5个月之久。由于发补的完成周期直接决定着上市日期，其推进速度自然成为客户尤其关切的问题。

依托公司一体化平台与团队丰富的经验，项目团队通过紧密的客户沟通，以及工艺研发、分析团队的通力协作，确保项目的高效推进。最终，团队仅用2个月就完成了杂质制备、清除研究、分析方法的开发和验证，以及批次分析等工作，确保了申报如期推进。

这种在关键时刻可靠执行、快速解决问题的能力，给客户留下了深刻的印象，客户感叹：“或许只有药明康德才能完成这种工作。”

图片来源：123RF

每一次信任，都是新的起点

后来，这款药物的所有权几经变更，但无论归属如何变化，有一个选择却从未动摇：该药物的后续生产，始终交由药明康德团队负责。

这段始于质疑的合作，最终转变成为跨越时间与变局的信任。

这份信任从来不是偶然。多年来，每一个环节的扎实落地，每一次问题的快速响应，背后都是药明康德一体化平台的能力与团队的智慧。正是这种紧密协作、价值共创的方式，让一次次交付不仅兑现了承诺，更赢得了长期并肩的默契。

而这样的案例，并非孤例。它们是药明康德团队在一次次攻坚中，反复打磨、沉淀下来的技术和能力的缩影。二十多年来，公司凭借高效、高质量的交付，持续将众多新客户转化为长期合作伙伴，并把每一次信任都视作新的起点。依托于一体化、端到端的CRDMO平台，药明康德将继续赋能全球客户，将科学创新更快、更稳地转化为造福患者的疗法。

From “Impossible” to “No Verification Needed”: How WuXi AppTec Earns Client Trust

Trust isn’t built in a day. It grows slowly, project by project, with consistent quality and efficiency. At WuXi AppTec, this is what everyday collaboration looks like: teams and clients achieving more together.

Several years ago, a client that was in negotiations to license a promising drug from a biotech company requested WuXi STA, a subsidiary of WuXi AppTec, to handle the manufacturing.

The synthesis of this molecule posed challenges: a single reaction step took nearly 20 days, the process was prone to side reactions, and yields fluctuated. In just two months, the WuXi STA team resolved the technical difficulties in the synthetic route through systematic analysis and process optimization, successfully completing technology mobilization and process qualification.

When the project timeline was presented, however, the biotech company’s reaction was not what anyone expected.

“That’s impossible,” the leadership team stated bluntly. “Your proposed timeline is nearly three times faster than our current vendor. Either the quality will suffer, or you’re exaggerating.”

Rather than defending their credibility with words, the project team turned to scientific demonstration.

They quickly produced a batch of samples for verification. The synthesis involved 10 reaction steps in total. After each step, the intermediate was sent to an independent lab designated by the biotech company for testing and release before the next step proceeded.

The biotech company’s approval came sooner than expected. Well before the end of the experiment, the biotech company was convinced: “No need for further verification. Let’s move on,” they said.

From then on, doubt gave way to trust, and the project moved forward. 

Leveraging Integrated Platform Capabilities to Overcome Key Challenges

A year later, the project had progressed to Process Performance Qualification (PPQ) manufacturing. Leveraging the integrated CRDMO platform, the project team partnered closely with the client to formulate a feasible plan and proactively identify potential risks. Despite tight deadlines and diverse requirements, they overcame multiple technical hurdles and made steady progress.

During process development, a key challenge was drying an intermediate to remove residual solvents in the original process. Leveraging their manufacturing experience and process platform, the team introduced a series of optimizations that brought residual solvents within specifications in a single drying pass—eliminating the need for the previously time-consuming drying cycles and significantly improving efficiency.

In analytical development, the team respected the client's dedication to their original analytical methods while strictly following the regulatory requirements of different regions. Leveraging the company's integrated analytical platform, they efficiently carried out over 50 method validations and verifications, standardized and structurally confirmed around 30 reference standards and impurities, and performed more than 10 stability and forced degradation studies. This comprehensive work provided solid support for advancing the project.

In just seven months, the team delivered the PPQ batches with “zero deviation” in quality and stability through close collaboration across process R&D, manufacturing, and analytics.

When the project reached the NDA submission stage, the team received the expected request for supplemental information. Because the project used submission materials based on another region, and regulatory standards vary by jurisdiction, more than a dozen items—mainly concerning manufacturing processes and analytical methods—required supplementation or revision during the review. Normally, that would take five months. But because the turnaround time for supplemental responses directly affected the launch date, the client was concerned about how quickly the team could move.

Leveraging the company’s integrated platform and the project team’s extensive experience, the team ensured efficient project execution through close client communication and seamless collaboration between process development and analytical development teams. They wrapped up impurity synthesis, purge studies, method development and validation, and batch analyses in just two months, on schedule for the submission.

The client was impressed by the team’s reliable execution and fast problem solving at key moments. “WuXi AppTec is one of the few that could have done this job,” they said.

With Each Trust, a Fresh Start

Over the years, ownership of this drug changed several times. But no matter who owned it, the WuXi AppTec team was always the one they trusted for subsequent development and manufacturing.

The partnership started with doubt, but over time it turned into trust that has lasted through every change.

Trust like this doesn’t happen by accident. Over the years, every step has been executed reliably and every issue has been addressed quickly. Behind it is the strength of WuXi AppTec’s integrated platform and the team’s deep expertise. This kind of close collaboration and shared success has transformed every delivery from a mere promise kept into a long‑standing partnership built on trust.

This is not an isolated case. It shows the technical expertise and capabilities that the WuXi AppTec team has built over years of challenging projects. For over twenty years, the company has turned many new clients into long-term partners by delivering on time with quality assurance. They have always treated every moment of trust as a fresh start. With its integrated, end-to-end CRDMO platform, WuXi AppTec will continue to enable clients worldwide to turn scientific innovations into life-saving treatments faster and more reliably.

免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

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